Kornimate/medical-research-clean huggingface dataset:
a study to learn about abrocitinib in adult patients with moderate to severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this non-interventional observational study is to learn about the safety and effects of the medicinal product (called abrocitinib) for the potential treatment of moderate to severe atopic dermatitis (ad). ad is a long-lasting disease that causes redness and irritation of the skin. this non-interventional study is seeking participants who is eligible for abrocitinib treatment according to the summary of product characteristics (smpc): * are aged at least 18 years old * have a confirmed diagnosis of ad by a skin doctor * decide to start treatment with abrocitinib as part of routine clinical practice * have a personally signed and dated informed consent document. this is used to indicate that the patient has been informed of all pertinent aspects of the study and data privacy aspects participants will take the medicinal product as prescribed in the real-world setting. we will examine the experiences of people receiving abrocitinib. this will help us determine if the medicinal product is effective and safe. participants will take part in this study for 3 months. during this time, participants will be followed up from the date of their first abrocitinib prescription for 12 months. during this non-interventional study, some participants may switch to other therapies after their initial abrocitinib therapy. we will follow these participants further when they switch therapy to monitor their experiences. participant documentation is expected quarterly as per standard clinical practice.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years * confirmed diagnosis of ad by dermatologist prior to study inclusion * patient for whom the decision to initiate treatment with abrocitinib was made as part of routine clinical practice irrespective of the patients being 1. abrocitinib naive or, 2. patients who reinitialize treatment with abrocitinib after being off treatment for ≥28 days prior to study inclusion * patient is eligible for abrocitinib treatment according to summary of product characteristics (smpc) * evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the non-interventional study exclusion criteria: * contraindications according to smpc * receipt of any investigational drug within 3 months or longer if required according to wash-out period prior to inclusion or participation in a clinical trial during observation period * patients being treated with abrocitinib within a time period of \<28 days prior to the timepoint of study inclusion * patients who are investigational site staff members or patients who are pfizer employees directly involved in the conduct of the non-interventional study * patients who are unable to consent

Keywords: atopic dermatitis abrocitinib jak inhibitors
effects and prognostic factors of intensive pulse light treatment for meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: the investigators are going to investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction.

enrolled patients are going to be randomly assigned to two groups. all of the patients will undergo four treatment sessions in total, which are two weeks apart. group 1 will undergo two sessions of intense pulsed light therapy with meibomian gland expression, as well as two sessions of intense pulsed light alone. group 2 will receive two sessions of intense pulsed light therapy alone, and two sessions of intense pulsed light therapy with meibomian gland expression. the following parameters will be measured at baseline, 2 weeks after the second treatment session, and 2 weeks after the fourth treatment session: tearfilm break-up time, oxford grade for corneal staining, meibomian gland expressibility, meibum quality, and ocular surface disease index.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of meibomian gland dysfunction exclusion criteria: * medical conditions in which ipl is contraindicated (pregnancy, breastfeeding, lupus, and any major uncontrolled health problem). * contact lens wearer * previous ocular surgery * previous thermal treatment for dry eye disease (e.g. lipiflow)
phenylephrine in septic shock

Conditions: Septic Shock

Summary: the present study was conducted as a prospective, randomized, controlled study to compare: * the effects of norepinephrine and phenylephrine on systemic and regional hemodynamics in patients with catecholamine-dependent septic shock * to test the hypothesis that norepinephrine may likewise better preserve hepatosplanchnic perfusion versus phenylephrine in patients suffering from septic shock

thirty two septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmhg despite adequate volume resuscitation will be enrolled in the study. patients will be randomly allocated to be treated with either a) titrated phenylephrine, b) titrated norepinephrine (control; each n = 16), to achieve a mean arterial pressure (map) between 65 and 75 mmhg, if necessary. data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, will be obtained at baseline and after 12 hours.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of septic shock * vasopressor support to maintain mean arterial pressure (map) between 65 and 75 mmhg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmhg and central venous pressure = 8-12 mmhg) exclusion criteria: * pregnancy * age \< 18 years * present cardiac dysfunction * present or suspected acute mesenteric ischemia

Keywords: sepsis septic shock phenylephrine norepinephrine catecholamine
naxitamab and granulocyte-macrophage colony stimulating factor (gmcsf) and isotretinoin for consolidation of patients with high-risk neuroblastoma in first remission.

Conditions: Neuroblastoma

Summary: this is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission. 120 patients will be enrolled to receive naxitamab + gm-csf in combination with isotretinoin.


Eligibility criteria:
inclusion criteria: 1. documentet neuroblastoma at time of diagnosis defined as 1. histopathology of solid tumor biopsy, or 2. bone marrow aspirate or biopsy indicative of neuroblastoma plus high blood or urine catecholamine metabolite levels 2. documented high-risk disease at time of initial diagnosis defined as 1. mync-amplified at stage l2, m or ms (according to international neuroblastoma risk group (inrg)) of any age or 2. mycn-nonamplified with stage m (according to inrg) and diagnosed at ≥ 18 months of age or 3. patient must have completed frontline therapy, and achieved one of the following: 1. verified complete response according to inrc (bone marrow positive minimal residual disease is allowed as assessed by rtqpcr at site) after completion of induction and consolidation with or without autologous stem cell transplantation 2. verified partial response according to inrc for primary site and soft tissue, bone, and bone marrow metastases at pre-autologous stem cell transplantation evaluation (i.e., myeloablative chemotherapy + autologous stem cell transplantation required as part of frontline regimen). furthermore, bone marrow response must be with ≤ 5% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy and bone response must be with ≤ 3 areas of abnormal uptake on 123i-mibg scintigraphy 4. age ≥ 12 months at trial enrollment exclusion criteria: 1. verified progressive disease during induction or consolidation therapy 2. any systemic anti-cancer therapy, including chemotherapy, within 3 weeks prior to enrollment 3. autologous stem cell transplantation within 6 weeks prior to enrollment or ongoing toxicity caused by the autologous stem cell transplantation at the discretion of the investigator 4. therapeutic 131i-mibg within 6 weeks prior to enrollment 5. prior anti-gd2 therapy 6. performance status of \< 50% as per the lansky scale (patients less than 16 years of age) or karnofsky scale (patients aged 16 years or older)

Keywords: antibody neuroblastoma pediatric naxitamab first remission
effects of neural mobilization with or without soft tissue mobilization in cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: this study will evaluate effects of neural mobilization with or without soft tissue mobilization in cervical radiculopathy, half of the subjects will receive treatment of neural mobilization along with soft tissue mobilization whereas half of the subjects will receive only neural mobilization.

neural mobilization and soft tissue mobilization both treatments are used to treat cervical radiculopathy but they work differently. neural mobilization technique is different for all 3 nerves i.e radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms. soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.

Eligibility criteria:
inclusion criteria: * patients with age 18 to 55years * patients having pain more than 3months * radiating pain in one of the upper limb * spurling's test positive exclusion criteria: * traumatic injury of upper limb or cervical spine * vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc) * patient asymptomatic for pain but symptomatic for tingling and paraesthesia * circulatory disturbance of upper extremity * known history of high level of spinal cord injury and malignancy * thoracic outlet syndrome

Keywords: cervical radiculopathy, neural mobilizations, soft tissue mobilization
using ni-es to treat spinal cord injury (sci)

Conditions: Spinal Cord Injuries; Pain, Neuropathic

Summary: ni-es therapy is a treatment that is being studied to potentially treat pain associated with sci and may help movement below the injury site.

the overall goal of this study is to assess the use of externally applied micro-current electrical stimulation in a subject with sci to reduce pain and patient perceived improvement of quality of life first, and second, movement below the sci injury. the hypothesis is that ni-es is beneficial in reducing pain following sci injury, patient perceived quality of life measures, and functional outcomes. we plan to achieve this goal by conducting a pain questionnaire and assessment of movement below the injury site prior to external micro-current electrical stimulation with the spinal stim (alpha-stim m with the ocular interface and the spinal interface) and again six weeks following the first treatment. these results will be used to characterize the extent and duration of any improvement in pain and movement as a result of treatment with the spinal stim.

Eligibility criteria:
inclusion criteria: * male or female * the presence of sci * pain associated with the sci * difficulty with body movement below the sci exclusion criteria: * absence of sci * poor health * deemed unsuitable for participation by the investigator.

Keywords: electrical stimulation, transcutaneous spinal cord injury neutrophic pain functional movements
bayq3939, 1000 mg tablet in transrectal needle biopsies of the prostate (trnbp) - infection prophylaxis

Conditions: Bacterial Infections

Summary: the primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin mr 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (trnbp).


Eligibility criteria:
inclusion criteria: * transrectal needle biopsy of the prostate required. * a clean-catch midstream-urine (msu) culture negative (\<104 cfu/ml) for possible pathogens at the pre-therapy visit prior to the trnbp. * gastrointestinal absorption is adequate as evidenced by passage of gas or feces per rectum and patient can tolerate oral food, fluids, and medication without vomiting or diarrhea. exclusion criteria: * history of hypersensitivity to ciprofloxacin or other quinolone antibiotics * valvular heart disease that requires antibiotic prophylaxis to prevent bacterial endocarditis * concomitant use of theophylline, probenecid, or warfarin at any time during the entire study * renal insufficiency * known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold * absolute neutrophil count (anc) \<1000/mm3 * human immunodeficiency virus (hiv) infection with a cd4 count \<200 cells/micl. hiv testing is not required * antibiotic administration within one week of the trnbp * severe hepatic insufficiency (child-pugh c)

Keywords: prevention of infectious complications transrectal needle biopsies of the prostate trnbp
pemetrexed and gemcitabine for treatment resistant patients with metastatic colorectal cancer and kras mutations

Conditions: Metastatic Colorectal Cancer

Summary: this study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with kras mutations.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma in colon or rectum * age \>18 * metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan. * kras mutation in primary tumour or metastasis. * measurable disease according to recist * ecog performance status 0, 1 or 2 * adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment) * edta clearance: uncorrected gfr \> 45 ml/min. * neutrophilocytes ≥1.5 x 10\^9/l, leukocytes ≥3.0 x 10\^9/l, thrombocytes ≥100x10\^9/l * alat ≤ 3 x upper normal value (uln), bilirubin ≤ 3 x upper normal value, aptt and inr normal (or 2-3 at ac treatment). (alat and basic phosphatase ≤ 5 x upper normal value in case of liver metastases). * blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research. * fertile men and women (women \<2 year after last menstruation) must use efficient birth control. * signed informed consent. exclusion criteria: * clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator. * other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix. * other experimental treatment within 30 days prior to treatment start. * pregnant or breastfeeding women. * clinical or radiological signs of cns metastases. * planned radiation of target lesions. * concurrent vaccination against yellow fever.

Keywords: colorectal cancer metastatic colorectal cancer treatment resistant chemotherapy refractory kras mutation
tap block: does volume make a difference?

Conditions: Post-operative Pain

Summary: patients who have abdominal surgery will experience pain from the incision. the lumbar tap block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. using ultrasound guidance, a solution of ropivacaine will be injected after surgery. the aim of this study is to determine the effect of changes in the volume of the injection.

pain from a surgical incision happens in most patients. during the perioperative period, the use of the tap block has been shown to reduce pain scores, opioid consumption and sedation scores. also, there is a trend towards a reduction of post-operative nausea and vomiting. the aim of the block is to reach the distal nerve endings of the abdominal wall from t6 to l1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar tap blocks. this is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.

Eligibility criteria:
inclusion criteria: * 18-70 years old * total abdominal hysterectomy * capable of completing informed consent * no previous chronic opioid use * no previous abdominal wall surgeries exclusion criteria: * patient refusal * contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, * local or systemic infection * local anesthetic allergy * bmi\>35

Keywords: tap block incision pain total hysterectomy
rapid diagnostic testing and artemisinin-based combination therapy for uncomplicated malaria by community health workers

Conditions: Uncomplicated Plasmodium Falciparum Malaria

Summary: the purpose of this study is to evaluate the efficiency of a rapid diagnostic test (paracheck pf) for the diagnosis of uncomplicated plasmodium falciparum malaria by community health workers at village level in tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs. the hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (coartem; novartis) by 30% without affecting the health outcome.


Eligibility criteria:
inclusion criteria: * fever * informed consent exclusion criteria: * severe clinical manifestations, which require immediate referral * pregnancy * previous enrollment in the study within the last 28 days
s100b in intensive care patients with and without traumatic brain injury

Conditions: Tumor; Brain Injuries; Trauma Injury; Critical Illness; Surgery--Complications

Summary: the neurotrophic protein s100b has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. on the other hand, s100b is a tumor marker. the interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination. in the present study we investigate the relevance of s100b as a prognostic factor, as well as the correlation with different ct classifications in a large cohort of patients with and without brain injury. furthermore, we examine whether s100b is elevated in brain tumors.

patients of the department of neurosurgery, university of erlangen-nuremberg, undergoing surgery for sellar lesions were prospectively included. the study protocol was approved by the local ethical committee. informed written consent was given by the participants or the next-of-kin in each case. exclusion criteria comprised of those below 18 years of age, pregnancy and a drug intolerance. patients baseline information included age, gender, clinical presentation, and preexisting medical conditions. in four different cohorts of patients, s100b was measured: 1. icu tbi, patients treated on the icu with brain injury 2. icu tumor, patients treated on the icu because of an intracranial tumor 3. icu surgery, patients treated on the icu following surgery without brain injury 4. icu control, patients treated on the icu without tbi, tumor or surgery the performed diagnostic tests included blood, cerebrospinal fluid and urine samples. in all subjects, blood (4 ml), cerebrospinal fluid (4ml) and urine (4ml) samples were collected daily as part of the clinical routine at 6:00 am. samples were immediately centrifuged for 10min at 1.300xg and 4°c and stored at a temperature of -80°c until the assays were performed. analysis was performed with commercially available kits on automated immunoanalyzers (liaison® sangtec®100 by chemiluminescence immunoassay, diasorin). the sensitivity of the assay was 0.02ng/ml. in all cohorts the clinical status was documented with glasgow coma score (gcs), and the outcome was assessed applying the glasgow outcome score (gos) or the karnofsky status scale. the radiological work-up included a computed tomography (ct) or a magnetic resonance imaging (mri). in brain injured patients, the ct was classifiied by the marshall and rotterdam score. extracranial injuries or surgical procedures were documented statistical analysis was performed with spss, and p\<0.05 was accepted as significant.

Eligibility criteria:
inclusion criteria: * patients of the department of neurosurgery, university of erlangen nürnberg, patients with traumatic brain injury, * patients with intracranial tumor, * intensive care patients, * informed written consent was given by the patient or the next of kin in each case. exclusion criteria: * age under 18 * pregnancy

Keywords: s100b biomarker ct-classification outcome histology
nih-aarp diet and health secondary research study based on oh95cn025 data

Conditions: Cancer; Mortality; Chronic Diseases

Summary: background: the nih and the american association of retired persons (aarp) conducted a diet and health study. it studied the links between diet, cancer, and cause of death in a group of middle-aged people in the u.s. researchers want to learn more about how diet and lifestyle can affect cancer and mortality. objective: to clarify links between diet, lifestyle, cancer, death, and chronic diseases. eligibility: aarp members ages 50 to 71 who took part in study #oh95cn025 and lived in california, florida, pennsylvania, new jersey, north carolina, louisiana, atlanta, or detroit in 1995 1996. design: this study will use existing data and samples. participants will not be contacted. participants personal data, like name, date of birth, and address, will be used. this data will be kept private. their data and samples will get a unique id. data from other follow-up studies will be used. cancer outcome data will be obtained from the 8 sample areas. many participants have moved to arizona, nevada, and texas. data will be obtained from those states as well. cause of death and date of death will be obtained from the national death index. cheek swab samples were gathered from 2004 to 2005. they will be used to study the oral microbiome. the university of washington (uw) will be added as a study site. uw will study air pollution. the process of linking with the virtual pooled registry cancer linkage system will be explored. it uses one system. right now, 11 state systems are used to get and link data. paper records will be stored in locked file rooms. electronic data will be stored on secure servers.

study description the purpose of this study is to analyze the data that have been collected as part of nih-aarp study (oh95cn025), a historical cohort; in this study we seek to continue to conduct research, but no new study activities will be requested from the study participants. objective to examine relationships between diet, lifestyle, and cancers by means of a prospective cohort design to examine relationships between diet, lifestyle, and mortality by means of a prospective cohort design to examine relationships between diet, lifestyle, and chronic diseases study population data and samples from 566,398 members of the aarp (formally the american association of retired persons), aged 50-71 years, and who resided in one of six states (california, florida, pennsylvania, new jersey, north carolina, and louisiana) or in two metropolitan areas (atlanta, georgia and detroit, michigan) in 1995-1996

Eligibility criteria:
* inclusion criteria: * aarp members * aged 50 to 71 years * resided in one of six states (california, florida, pennsylvania, new jersey, north carolina, and louisiana) or in two metropolitan areas (atlanta, georgia and detroit, michigan) in 1995-1996

Keywords: nutrition prospective cohort lifestyle factors cancer mortality natural history